Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexuall… (NCT07039591) | Clinical Trial Compass
RecruitingEarly Phase 1
Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA
United States60 participantsStarted 2025-08-08
Plain-language summary
A randomized open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA
Who can participate
Age range18 Years – 49 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Cisgender female aged 18-49 years old, inclusive, at screening based on self-report.
2\. Sexually active, defined as having penile-vaginal sex at least once a week, on average, over the past three months with the same male partner, and intends to continue having sexual intercourse at the current frequency for at least three months.
3\. Healthy based on medical history, physical exam (including pelvic exam with visual inspection) at screening.
4\. Using effective non-vaginal method of contraception (oral contraception, injectable, patch, IUD, sterilization, male condoms) 5. Competent to provide written informed consent based on Investigator's assessment.
6\. Agrees to not participate in any other clinical research involving investigational or marketed products for the duration of this trial.
Exclusion Criteria:
* 1\. Known or suspected allergy to silicone or EVA, as reported by participant. 2. Positive pregnancy test at screening or enrollment based on urine hCG test. 3. Positive for HIV at screening based on rapid test per site SOPs. 4. Presence of any clinically significant genital epithelial findings (e.g. abrasions, ulcerations, lacerations, or vesicles) at screening.
5\. Positive chlamydia, gonorrhea, or trichomoniasis test at screening. 6. Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract infection (UTI) at screening. (Participants who are symptomatic at initial screening will be referred for test…
What they're measuring
1
Mean Acceptability Score per IVR
Timeframe: From enrollment to the end of treatment at approximately 13 weeks